Evaluating Inclusion and Exclusion Criteria in Clinical Trials; Public Meeting

Streszczenie

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled "Evaluating Inclusion and Exclusion Criteria in Clinical Trials." Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, the purpose of the public meeting is to bring the stakeholder community together to discuss a variety of topics related to eligibility criteria in clinical trials and their potential impact on patient access to investigational drugs, and how to facilitate the enrollment of a diverse patient population.